Associate Consultant - CMC Development & Analytics
ZS · South San Francisco, CA · 2 wk ago
HybridBusiness DevelopmentFull-time
About the role
ZS is seeking a Decision Analytics Associate Consultant in its Supply Chain and Manufacturing practice. This role focuses on supporting client engagements in pharmaceutical CMC development, process science, biologics manufacturing, and tech transfer. Key responsibilities include solving client questions related to drug substance and drug product development, process development, tech transfer, process validation, and regulatory readiness.
Responsibilities
- Apply CMC, process science, and analytical skills to solve client questions related to pharmaceutical development, manufacturing, tech transfer, process validation, and regulatory readiness.
- Support client engagements focused on biologics manufacturing and development; small molecule experience is also relevant.
- Work collaboratively with clients to understand business needs, technical requirements, available data sources, and decision-making priorities.
- Analyze data from CMC, manufacturing, quality, regulatory, and development systems to generate actionable insights.
- Support projects involving drug substance, drug product, process development, formulation, analytical chemistry, tech transfer, process validation, and related CMC functions.
- Help clients think through future lab setups, lab operating models, digital lab capabilities, and ways to accelerate drug development.
- Contribute to the design of future-state CMC and lab operating models, including processes, roles, systems, data flows, and technology enablement.
- Translate scientific, manufacturing, and analytical findings into clear recommendations for client stakeholders.
- Communicate results with an emphasis on answering the client’s business question, not just explaining the analytical process.
- Right-size deliverables based on client needs, project scope, timeline, and stakeholder expectations.
- Support project planning, workstream execution, deliverable development, and day-to-day client engagement.
- Build expertise across CMC analytics, biologics development, process science, pharmaceutical manufacturing, and digital transformation topics.
- Upskill on new CMC concepts, therapeutic modalities, analytics methods, and emerging technologies relevant to client challenges.
- Contribute to ZS’s Supply Chain and Manufacturing practice development through knowledge assets, reusable tools, and thought leadership.
Requirements
- Bachelor’s or master’s degree in Chemical Engineering, Biochemical Engineering, Mechanical Engineering, Materials Engineering, Chemistry, Biotechnology, Pharmaceutical Sciences, or a related technical discipline; PhD may substitute for work experience.
- At least 2.5 years of relevant pharmaceutical or biopharmaceutical CMC experience, preferably with biologics; small molecule experience is also acceptable.
- Hands-on experience in at least one CMC function, such as process development, process engineering, process chemistry, formulation, analytical chemistry, drug substance manufacturing, or drug product manufacturing.
- Strong process science foundation, including understanding of unit operations, process characterization, scale-up, tech transfer, process validation, manufacturing readiness, QbD, CQAs, CPPs, and control strategy.
- Familiarity with CMC regulatory milestones, submission requirements, and systems such as ELN, LIMS, ERP, LCM, PLM, MES, or related platforms.
- Experience using data analytics, modeling, reporting, visualization, AI-enabled tools, or technology solutions to generate insights and accelerate CMC development.
- Some consulting or client-facing experience, including working with clients, right-sizing deliverables, managing stakeholder expectations, and communicating recommendations clearly.
- Strong communication, problem-solving, attention to detail, teamwork, ownership, adaptability, and client-first mindset.
- Fluency in English.
Qualifications
- Client-first mentality.
- Intense work ethic.
- Collaborative spirit and problem-solving approach.
Skills
- Process science foundation.
- Data analytics and modeling skills.
- Communication and presentation skills.
- Project management and client relationship management skills.
Benefits
At ZS, we offer a comprehensive total rewards package that supports your health and well-being, financial future, time away, and professional development. This includes:
- Milestone training programs aligned to career progression opportunities.
- Internal mobility paths that empower growth via s-curves, individual contribution, and role expansions.
- Cross-functional skills development & custom learning pathways.
- Flexible and connected work model.
- Hybrid working model.
- Travel opportunities.
Pay
Competitive compensation and benefits package.
Schedule
Flexible work schedule to accommodate client needs and personal commitments.